Axium Neurostimulator System
FDA premarket approval P150004/S051 · decided 2021-08-05
Approval details
- PMA number
- P150004
- Supplement
- S051
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Axium Neurostimulator System
- Generic name
- Dorsal root ganglion stimulator for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2021-07-07
- Decision date
- 2021-08-05
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- PMP
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Approval of the revised protocol for the post-approval study (PAS) requesting removal of 18- and 24-month follow-up visits.
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